Qu'est ce que le test prénatal Harmony™ ?

Harmony is a non-invasive, cell-free DNA-based blood screening test that assesses the risk of fetal trisomy 21, 18, and 13 in women of any age or risk factors†. Harmony has a detection rate of greater than 99% and a false-positive rate of less than 0.1% for trisomy 21.1

The Harmony test can be performed as early as 10 weeks’ gestation, and results are received in as little as 3 days, most in 5 days after sample receipt.

Harmony uses a directed (targeted) approach, analyzing only the chromosomes of interest. This, along with the measurement of fetal cell-free DNA contribution using single-nucleotide polymorphism (SNP), yields robust and accurate results.7

Yes. Harmony includes the option of testing for the following conditions: monosomy X, XXX, XXY, XYY, and XXYY.

Comment puis-je prescrire le test prénatal Harmony ?

Following confirmation of a pregnancy, order Harmony as early as 10 weeks gestational age. Administer a simple blood draw directly or through a participating laboratory and send it to Ariosa Diagnostics using the specimen collection and transportation kit. Receive a report detailing test results in as little as 3 days, most in 5 days after sample receipt. Harmony can be used in conjunction with NT ultrasound. Patient education is similar to that required for conventional trisomy screening tests.

Many U.S. insurance plans include coverage of the Harmony Prenatal Test. In addition, the makers of Harmony, Ariosa Diagnostics, offer three assistance programs to help provide access to the test for any pregnant woman regardless of age or risk. Please note, the Harmony Access Program is only available in the United States and U.S. Territories.

Is the Harmony Prenatal Test validated for use in pregnancies of any age or risk?

The Harmony Prenatal Test is validated for pregnant women of any age or risk categories, including both under 35 and over 35 age groups (studies have included women ages 18-48). In fact, recent landmark study published in the New England Journal of Medicine showed that Harmony significantly outperformed first trimester screening in both trisomy 21 detection rate and false-positive rate.1

In blinded prospectivestudies of over 22,000 pregnant women ages 18-48, Harmony’s false-positive rate was less than 0.1%.1-2,8-9,11 False-positive rates for most conventional screening tests are generally around 5%.4

Positive predictive value (PPV) is the probability that a positive test result is a true positive. PPV is based on both the performance of the test and the prevalence of the condition in a particular population. In blinded published studies, Harmony has been shown to have a PPV of 93% in the high-risk populationi and 81% in the general populationii.1-2 In contrast, first trimester serum screening has a PPV of 6% in the high-risk population or in a 35-year-old population.

The Harmony test is a screening test that delivers clear answers* as early as the first trimester with a single blood draw. Other conventional tests for Down syndrome are performed later in pregnancy and may require multiple office visits. Traditional serum screening tests are associated with a false-positive rate as high as 5%.4 Harmony uses a unique method of targeted DNA analysis that, combined with extensive quality controls, achieves over 99% in detection rate and a false-positive rate of less than 0.1% for trisomy 21.1

Only the Harmony test uses a unique targeted approach (DANSRTM and FORTETM) to more accurately assess the chromosomes of interest. In addition, Harmony’s methodology includes SNPs analysis which distinguishes maternal from fetal DNA and quantifies the fetal DNA. 7, 12 The amount of fetal DNA is incorporated into the risk assessment and reported in the final test result; each patient receives an individualized risk score. 7

*The Harmony Prenatal Test is developed by Ariosa Diagnostics. Ariosa Diagnostics is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this testing service has not been cleared or approved by the US FDA or any other federal regulatory agencies.Non-invasive prenatal testing (NIPT) services based on cell-free DNA analyses are not diagnostic; results should be confirmed by diagnostic testing.Data have not been submitted to or evaluated by Federal regulatory agencies and the test is not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.